Overview
Sterilization Control Assurer (12 Months fixed term) Jobs in Arroyo, Puerto Rico at Stryker
Title: Sterilization Control Assurer (12 Months fixed term)
Company: Stryker
Location: Arroyo, Puerto Rico
What You Will Do
As a Sterilization Control Assurer, you will be responsible for ensuring that sterilization processes are properly validated, maintained, and compliant with all applicable regulatory and quality standards. You will oversee sterilization cycles, monitor environmental controlled areas, and support product adoption activities while guaranteeing product sterility. Additionally, you will work closely with cross-functional teams to evaluate processes, review documentation, investigate non-conformances, and ensure that all products released meet strict regulatory requirements.
Main Responsibilities
- Ensure compliance with sterilization control regulatory requirements for the production and release of sterile products
- Maintain full adherence to quality systems and applicable standards (e.g., QSR, ISO)
- Review and maintain documentation and procedures according to current regulatory requirements
- Monitor sterilization control systems and environmental controlled areas (ECA)
- Support batch record review and final product release processes
- Track and analyze performance metrics, trends, and audit results to identify improvement opportunities
- Evaluate changes impacting sterilization processes to ensure compliance
- Conduct investigations of non-conformances and deviations
- Recommend and implement corrective and preventive actions (CAPA)
- Support audits and ensure continuous process compliance
What You Need
Required:
- Bachelor’s degree in Science or related field (Biology or Microbiology preferred)
- 3–5 years of experience in Quality or Compliance within an FDA-regulated environment
- Strong knowledge of medical device regulations and standards (QSR, ISO 13485, ISO 11135, ISO 11137, ISO 14644, ISO 10993)
- Hands-on experience with sterilization validation, cycle monitoring, and cleanroom and/or EO/Gamma sterilization technologies
- Solid background in microbiology, sterility testing, and non-conformance investigations (including root cause analysis and CAPA)
- Proven experience in documentation control, batch record review, and product release within a quality system
- Experience with audits, process monitoring, trending, and continuous improvement initiatives
Preferred:
- Certifications or training in Sterilization, Lean Six Sigma, Lead Auditing, Risk Management, or Train-the-Trainer; experience acting as SME in sterilization or microbiology
United States of America Pay Ranges:
- USN: $69,500 – $110,900 USD Annual
- Puerto Rico: $69,500 – $110,900 USD Annual
- US5: $73,000 – $116,400 USD Annual
- US10: $76,500 – $122,000 USD Annual
- US15: $79,900 – $127,500 USD Annual
- US20: $83,400 – $133,100 USD Annual
- US30: $90,400 – $144,200 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
